Dealing with Specific Situations

Maryland CDC Colorectal Cancer Program Policies and Procedures March 5, 2010

Roles and Responsibilities

The Maryland CDC Colorectal Cancer (CRC) Program is a cooperative agreement with the Centers for Disease Control and Prevention (CDC) that began in July 2009 and is designed to increase population-based CRC screening among persons 50 years and older in Maryland. Screening efforts are to be focused on persons in Baltimore City 50 years and older with low incomes and inadequate or no health insurance coverage for CRC screening.

The Maryland Department of Health and Mental Hygiene (DHMH) is the recipient of CDC funds for the Screening Program. DHMH shall: o interface with CDC on all program aspects of the Program; o distribute grant awards and funds for screening to the Sites (see below); o convene the CRC Medical Advisory Committee; o develop policies and procedures for the program consistent with the CDC requirements; o assist the Sites in developing their Site-specific procedures; o develop data systems, collect data from the Sites, and report data to CDC; and o take responsibility for site visits, quality assurance, fiscal oversight, and reporting to CDC.

The screening “Sites" shall: o Comply with Grant Agreement between DHMH and the Site, including, but not limited to:  hire and supervise the designated “administrative case manager” for each Site’s program;  perform in-reach and out-reach to identify clients potentially eligible for screening;  determine eligibility, enroll, and case manage the clients for their CRC screening and after-care;  enter into an electronic database and report to DHMH the Site’s clinical and fiscal data; and  manage the administrative and fiscal components of the DHMH grant.

The Medical Case Manager at the Sites shall: o take the medical and legal responsibility for screening clients for CRC; o make medical decisions about the client and assume liability for those decisions; o obtain informed consent before the colonoscopy or other medical procedure; and o perform procedures according to contract specifications, including reporting clinical results and billing information.

As the Program develops, there may be additional roles and responsibilities required by the CDC and not covered above that will be discussed with the Sites to determine how to address them. 05b2f240d93819f0aaaa012c1d43b464.doc 1 Maryland CDC CRC Program Policies and Procedures

Program Coverage and Rates a. The following CRC tests for screening or surveillance, or for diagnostic or follow-up services shall be reimbursable. The allowed CPT codes and their Medicare rates are found in the Procedures Manual, Section 9--Contract and Billing, Section 9B.

i. Fecal occult blood testing: guaiac-based or fecal immunochemical testing; ii. Sigmoidoscopy including colonoscopist fees, facility fees; anesthesiology; pharmacy; iii. Colonoscopy (with and without biopsy(ies))including colonoscopist fees, facility fees; anesthesiology; pharmacy; iv. Barium enema, double contrast; v. Office visits related to colonoscopy: Pre colonoscopy or post colonoscopy visit or both, if provider requests; vi. Bowel preparation products; vii. Pathology fees including technical component and professional component; special stains and immunocytochemistry; viii. Pre colonoscopy: EKG and bloodwork, if deemed necessary and listed in Attachment 9B, or with approval of DHMH and CDC; and ix. Other pre-colonoscopy testing with prior approval by DHMH and CDC. b. The following shall not be reimbursable without prior approval by DHMH (and by CDC): i. Screening tests recommended by the Medical Case Manager at an interval sooner than recommended in Attachment 1; ii. CTs (computerized tomographs) as a primary screening test or for staging or other purposes; iii. Surgery or Surgical staging, unless specifically required and approved by the Medical Advisory Committee to provide a histological diagnosis of cancer; iv. Any treatment related to the diagnosis of colorectal cancer; v. Any care or services for complications that result from screening or diagnostic test provided by the program; vi. Evaluation of symptoms for patients who present for CRC screening but are found to have gastrointestinal symptoms; vii. Diagnostic services for clients who had an initial positive screening test performed outside of the program, including a positive fecal occult blood test; viii. Evaluation of underlying medical conditions prior to colonoscopy if such evaluation includes chest X-rays, coagulation studies, treadmill testing, pulmonary function tests, or cardiology or pulmonary consultation (patients medically cleared for colonoscopy may return for enrollment into the program after clearance); ix. Management of medical conditions including inflammatory bowel disease (e.g., surveillance colonoscopies and medical therapy); x. Genetic testing for patients who present with a history suggestive of a HNPCC or FAP; xi. Co-pays or deductibles for individuals with healthcare insurance; and xii. Use of propofol as anesthesia during endoscopy. (If propofol is used during endoscopy procedures, reimbursement will be based on the rate for standard anesthesia routinely used at that facility.)

05b2f240d93819f0aaaa012c1d43b464.doc 2 c. Payment rates: i. Services are reimbursable at the Health Services Cost Review Commission (HSCRC) rate for HSCRC regulated services, or, for unregulated services, at a rate no higher than the Medicare rate for the Region. ii. CDC funds shall not pay the co-payment or deductible fees for a patient who otherwise has insurance coverage for CRC screening services.

Policies Procedures General Focus  Sites shall focus screening efforts on asymptomatic > 75% of screening services should be spent on screening people at average people between the age of 50 and 64 years who are at risk. average risk of CRC: o No personal or family history of CRC or adenomas o No history of inflammatory bowel disease (ulcerative colitis or Crohn’s colitis) o No personal or family history of genetic syndromes (see below)  Sites shall refer ineligible clients to appropriate medical Sites will have lists of referrals sites where ineligible clients may be referred. care and shall note the number of ineligible clients who Sites will have a data collection form on which to record ineligibles and the contact the program, the reason for ineligibility, and the site of referral. site to which the person was referred. Residence, Age, Income Sites shall enroll clients for CRC screening by colonoscopy Sites will obtain verbal documentation of residence in Baltimore City, age, if they meet the program’s requirements for: risk, and household income < 250% of the Federal Poverty Guideline as  Residence: resident of Baltimore City (or, with DHMH minimum eligibility for screening. approval, resident of Maryland outside Baltimore City)  Age: Sites will contact DHMH to obtain approval to screen if the client is outside  if average risk: 50 to 64 years old, or 65+ years old of these guidelines. with DHMH approval  if at increased risk due to family or personal history (see below): 18 to 64 years old, or 65+ years old with DHMH approval  Income (household income):  <250% of Federal Poverty Guideline 05b2f240d93819f0aaaa012c1d43b464.doc 3 Policies Procedures Insurance Sites shall enroll clients who are: Sites will interview clients about their insurance status and record it on the  uninsured, data collection form. Those not eligible will be referred to other sites for care.  insured with Medicare Part A only, or  insured with other commercial insurance that does not cover CRC screening; Sites shall not pay co-pays or deductibles for clients with insurance

Family History Sites shall not enroll clients who have been previously Sites will refer the person to sites that offer genetic testing and management. diagnosed with a genetic syndrome associated with CRC If the person is found NOT to have FAP or HNPCC based on genetic testing, (FAP or HNPCC). then the person may reapply to enroll in the program. Sites shall not enroll clients with a family history of a genetic syndrome associated with CRC (FAP or HNPCC). Sites shall enroll clients with increased risk because of a Sites will screen people with increased CRC risk according to Attachment 1. family history of a first degree relative (FDR) with CRC or polyps, either adenomatous, hyperplastic, or other/unknown type. Personal History Sites shall enroll for surveillance colonoscopy clients with  Sites will enroll clients diagnosed with CRC for colonoscopy, as CRC previously diagnosed outside of the project or who recommended by their Medical Case Manager at intervals detailed in were in the CDC Screening Demonstration Program who Attachment 1. Sites will refer clients with gastrointestinal symptoms and otherwise meet eligibility criteria. a past personal history of CRC back to their prior source of health care or referred to a provider on a list of referrals (See Symptoms and Signs, below). Sites shall not enroll clients previously diagnosed with a  Sites will tell clients who have prior diagnosed FAP or HNPCC that they genetic syndrome associated with CRC (FAP or HNPCC). should continue in the care of their prior provider or be referred to a provider on a list of referrals. Sites shall not enroll clients with IBD/ ulcerative colitis/  Sites will attempt to obtain more information on clients who report Crohn's colitis. unspecified “colitis” before denying enrollment.  Sites will refer clients who come to the program who have prior diagnosed IBD back to their prior source of health care or refer to a provider on a list of referrals.

05b2f240d93819f0aaaa012c1d43b464.doc 4 Policies Procedures Sites shall enroll clients with a personal history of polyps, Sites will enroll clients with a history of adenoma(s), hyperplastic polyp(s) or either adenomatous, hyperplastic, or other/unknown type. other/unknown type of polyps for surveillance colonoscopy at an interval recommended in Attachment 1.

For clients with past history of adenomas, hyperplastic polyps, or of polyps of unknown type or unknown number:  Sites will try to determine the type and number of polyps found in the past and the clinician’s recommended interval; clients will be eligible if the colonoscopy in the program will be at or later than the recommended time of recall for colonoscopy. See Attachment 1.  Clients for whom sites cannot determine the number and type of polyps will assume they were adenoma(s) and follow recall guidelines of the program. See Attachment 1. Sites shall refer clients who may not benefit from screening  Sites will make clinics/providers who will refer clients to the screening (e.g., people with advanced age or people with short-life program aware of the priority population for this program and the expectancy due to extreme co-morbidity) to providers for restrictions on clients who may not benefit from screening such as those clearance prior to colonoscopy. with short life expectancy or extreme co-morbidity; they will ask clinics/providers NOT to refer these clients the program and will make clinics/providers aware that the program will NOT cover additional procedures and consults for colonoscopy clearance.  Sites will ask potentially eligible clients about their co-morbidity(ies) using the data collection form and will refer those with co-morbidities to the person’s primary care provider or to endoscopists for evaluation prior to colonoscopy; sites will NOT cover additional procedures for clearance for colonoscopy (e.g., treadmill, pulmonary function testing, chest X-ray) without prior approval by the DHMH.

05b2f240d93819f0aaaa012c1d43b464.doc 5 Policies Procedures Symptoms and Signs Prior to enrolling a client who is otherwise eligible by  Sites will make clinics/providers that will refer clients to the screening criteria above, Sites shall evaluate each client for program aware of the restrictions on symptomatic clients and will ask symptoms. clinics/providers NOT to refer clients to the program who have symptoms listed in Column 1 or who have a mass on physical exam. People with significant gastrointestinal symptoms or signs  Sites will ask potentially eligible clients about their recent GI symptoms are not eligible for screening services through the CRCCP. (see data forms); Symptoms and signs that would preclude eligibility for the  Sites will refer a person who reports a GI symptom listed in Column 1 or program include, but are not limited to: an asymptomatic person who is found to have a rectal or abdominal mass 1. Rectal bleeding, bloody diarrhea, or blood in the to a provider on the Referral List; sites will record the reason for stool within the past 6 months (bleeding that is exclusion from the program. known or suspected to be due to hemorrhoids after  People presenting with symptoms listed in Column 1 need a complete clinical evaluation would not prevent a client from evaluation by a clinician to determine the cause of their symptoms. This receiving CRC screening services); evaluation, and any potential subsequent treatment, is beyond the scope of 2. Prolonged change in bowel habits (e.g., diarrhea or this program. If a client has been referred, medically evaluated, and constipation for more than two weeks that has not cleared for colorectal cancer screening, then the site may enroll the client been clinically evaluated); in the program if all eligibility criteria are met including the determination 3. Persistent abdominal pain; that symptoms were not from CRC. 4. Symptoms of bowel obstruction (e.g., abdominal  For individual cases when clients present with minor symptoms that are distension, nausea, vomiting, severe constipation); not listed in Column 1, the Site should consult with the DHMH regarding 5. Significant unintentional weight loss of 10% or more eligibility. of starting body weight; or 6. Mass in the abdomen or rectum on physical exam.

05b2f240d93819f0aaaa012c1d43b464.doc 6 Policies Procedures Prior CRC Screening Provided the client meets the above residency, income,  Sites will interview clients to determine past CRC screening to insurance, risk history, health, and symptom eligibility determine eligibility. Sites will attempt to document prior screening criteria, the person shall be eligible for colonoscopy if s/he: results. Sites will record this information on the Screening Forms.  Was never screened for CRC in past;  A person with recent fecal occult blood testing that is positive for blood  Is at average risk and had: is not eligible for the program and should be referred for diagnostic o Colonoscopy in past with no CRC or adenomas testing. found and it has been at least 10 years since last colonoscopy; o Flexible sigmoidoscopy or double contrast barium enema (DCBE) negative for polyps or CRC at least 5 years ago; o Negative FOBT at least 1 year ago and no colonoscopy, flexible sigmoidoscopy, or DCBE that would exclude the person;  Is at increased risk and needs screening or surveillance colonoscopy: o Family history of CRC or adenoma(s) (see Attachment 1 for age and interval). o Personal history of colonoscopy in past with finding of adenoma(s) or unknown type of polyps, now in need of repeat colonoscopy (See Attachment 1 for eligible interval). o Was screened with inadequate colonoscopy within the CDC CRC Screening Program Inadequate Colonoscopy in the Program Sites shall obtain from the Medical Case Manager the  Sites will obtain and record in the Medical Record the Medical Case recommended procedure (e.g. repeat colonoscopy or DCBE) Manager’s recommendation for completing the screening after inadequate and its timing following a colonoscopy with inadequate colonoscopy. Sites will schedule a repeat colonoscopy or other procedure bowel prep or when the endoscopist failed to reach the to complete screening. cecum.

05b2f240d93819f0aaaa012c1d43b464.doc 7 Policies Procedures Unplanned Events/Complications  If an unplanned event or complication occurs during or  Sites will instruct clients to call the endoscopist if any bleeding, within 30 days after the procedure, Sites shall obtain abdominal pain, fainting, etc. occurs after the procedure; if the information and notify DHMH by e-mail or telephone. complication or unplanned even occurs after hours or in an emergency DHMH shall notify CDC on the next monthly call situation, clients should be instructed to follow their endoscopist’s  If there is a serious complication including but not instruction, call 911, or go to an emergency room. limited to: colon perforation, stroke, heart attack, or  Sites will tell clients to identify themselves as a participant in the CDC death, the Site shall notify DHMH within 24 hours of CRC Screening Program being made aware of the event/complication. DHMH  Sites will give the clients a program number to call to report the shall notify CDC on the next working day. unplanned event/complication.  Confirmed complications that result in an emergency  Sites will send a follow up letter with results and recall recommendations room visit, hospitalization, or death shall be reported in to clients screened. the client’s medical record and in the clinical database  Sites will contact clients at 30 days after procedure to ascertain current record. health status and unplanned events/complications.  Sites will record specific information in the medical record and in the client’s clinical database record. Tracking and Reminder Systems Sites shall implement client tracking and reminder system(s)  Sites will maintain a paper system for recalling clients unless a recall to support screening adherence, provision of appropriate and system will be found in the DHMH-provided data management system. timely follow-up of abnormal screening results, monitoring for complications after endoscopy, DCBE, or rescreening.

05b2f240d93819f0aaaa012c1d43b464.doc 8 Policies Procedures Diagnosis and Treatment for Cancer or Complications  Sites shall case manage and attempt to obtain coverage  Sites will identify, in advance, personnel who will assist the client in to pay for further diagnosis and treatment of clients applying for Medicaid (Maryland Medical Assistance). found to have cancer, suspected cancer, or who need  Sites will discuss, in advance, with their administration the possibility of removal/resection of complex, “worrisome” adenoma(s). putting the program clients under the hospital’s uncompensated care  Sites shall case manage and attempt to obtain coverage policy so that the client will not get any bills for the to pay for treatment of clients who experience an hospitalization/operating room/in-client pharmacy bills. unplanned event or complication felt to be due to  Sites will discuss, in advance, with appropriate colonoscopy. surgeons/oncologists/radiation oncologists issues of payment for care and will have worked out a plan.  Sites will help the client apply for Medical Assistance.  If not eligible for Medical Assistance, sites will work with DHMH to try to get eligible client’s care paid for by the Maryland Cancer Fund (if funding is available).  If these are not possible, then Sites will work with hospital, providers, pharmacy, Med Bank, etc. to assure client gets diagnosis/treatment.  Sites will record the client outcome (surgery/treatment/findings, etc.) and the source(s) of payment in the client’s medical record and in fields provided in the client database. Data Management  Sites shall enter required data regarding demographics,  DHMH will provide program-specific software for client data and sites risk and screening history, clinical screening and will install the software and enter data in a timely manner. diagnostic procedures and findings, and complications in  Sites will submit data to DHMH when required and work with DHMH a database provided by DHMH staff to resolve edit errors on the data.  Sites shall enter or provide to DHMH required data  DHMH will send data to CDC per CDC guidelines regarding patient-level reimbursement cost data related to screening and program-related activities of staff.  Sites shall establish appropriate billing procedures to handle receipt, approval and payment of bills.  Sites shall establish internal procedures to account for program expenditures of personnel, fringe, and administration and report to DHMH for reimbursement. Eligibility for the program is summarized in Attachment 2, Summary of Eligibility for CRC Screening in the CDC Colorectal Cancer Control Program, January 2010 05b2f240d93819f0aaaa012c1d43b464.doc 9 SEE SEPARATE DOCUMENT for Attachment 1:

1A_Attachment 1: Guidelines for Screening and Surveillance for Early Detection of Colorectal Polyps and Cancer+ Colorectal Cancer (CRC) Medical Advisory Committee, Maryland Department of Health and Mental Hygiene March 2009

05b2f240d93819f0aaaa012c1d43b464.doc 10 Attachment 2. Summary of Eligibility for CRC Screening in the CDC Colorectal Cancer Control Program April 2010 Character Eligible for Colonoscopy Ineligible for Program -istic (Screening or Surveillance) Residence Baltimore City resident Residence address outside of Baltimore City . Verbal report to verify residence Income Household income < 250% of the Federal Poverty Household income >250% of the FPG Guideline (FPG)  Verbal report to verify income Insurance  Uninsured  Medicare parts A&B Status  Medicare part A only  Medical Assistance  Insured but no coverage for CRC screening  Insured with coverage for CRC screening procedures (program cannot pay co-pays or deductibles. Even if client meets income criteria and does not have money to pay co-pay or deductible, the client is not eligible.) Age and 50—64 years and at average risk of CRC  <18 years old Risk Average risk is defined as:  IBD (ulcerative colitis or Crohn’s disease)** Factors  no personal or family history of CRC or  Personal history of Familial Adenomatous adenomas; and Polyposis (FAP) or Hereditary non-  no personal history of Inflammatory polyposis colorectal cancer (HNPCC) Bowel Disease (IBD), FAP or HNPCC,  Family history of FAP or HNPCC in first endometrial or ovarian cancer degree relative 18—64 years if increased risk of CRC due to  18-49 with history of hyperplastic polyps the following:*  65+ years unless approved by DHMH  personal history of colorectal adenomas or polyps of unknown type  personal history of CRC previously diagnosed outside of the program who are asymptomatic and have had curative treatment  CRC diagnosed within the program  personal history of ovarian or endometrial cancer  family history of first degree relative with CRC, adenomas or polyps of unknown type 65+ years with DHMH approval

*See Attachment 1 for age to begin screening in ** people with non-specific “colitis” may be those at increased risk eligible if confirmed that they have not had IBD Health  Healthy people  People whose medical provider doesn’t clear Status  People with co-morbid medical conditions for screening colonoscopy because of co- and (for example, severe heart or lung disease) morbid conditions or advanced age Advanced and people of “advanced age” if cleared by  Co-morbid conditions that require procedures Age medical provider for colonoscopy that are beyond the capability of the program to gain clearance for colonoscopy (for example, cardiac treadmill test; pulmonary function tests, extensive blood work, etc.)

05b2f240d93819f0aaaa012c1d43b464.doc 11 Character Eligible for Colonoscopy Ineligible for Program -istic (Screening or Surveillance) Symptom  Signs and symptoms NOT listed in column to Anyone with the following: s/ Signs the right as Ineligible for the program  Rectal bleeding, bloody diarrhea, or blood in exclusions; signs and symptoms if cleared by the stool within the past 6 months (bleeding medical provider for colonoscopy as NOT that is known or suspected to be due to being suggestive of CRC hemorrhoids after clinical evaluation would not prevent a client from receiving CRC screening services);  Prolonged change in bowel habits (e.g., diarrhea or constipation for more than two weeks that has not been clinically evaluated);  Persistent abdominal pain;  Symptoms of bowel obstruction (e.g., abdominal distension, nausea, vomiting, severe constipation);  Significant unintentional weight loss of 10% or more of starting body weight; or  Mass in the abdomen or rectum on physical exam.

Past Provided the client meets the above residency,  Past positive flexible sigmoidoscopy or DCBE screening income, insurance, risk history, health, and now needing diagnostic testing symptom eligibility criteria, the person shall be  Up to date screening with either colonoscopy, eligible for colonoscopy if s/he: FOBT plus flexible sigmoidoscopy,  Was never screened for CRC in past; sigmoidoscopy or DCBE according to the  Is at average risk and had: Program Guidelines—See Attachment 1: o Colonoscopy in past with no CRC or o Negative FOBT in past year adenomas found and it has been at least o flexible sigmoidoscopy or DCBE within 10 years since last colonoscopy; past 5 years; o Flexible sigmoidoscopy or double o Colonoscopy with colonoscopy recall contrast barium enema (DCBE) negative date (per Program Guidelines--See for polyps or CRC at least 5 years ago; Attachment 1) later than the date of o Negative FOBT at least 1 year ago and no proposed screening/surveillance in the colonoscopy, flexible sigmoidoscopy, or City program DCBE that would exclude the person;  Recent positive FOBT  Is at increased risk and needs screening or surveillance colonoscopy: o Family history of CRC or adenoma(s) (see Attachment 1 for age and interval). o Personal history of colonoscopy in past with finding of adenoma(s) or unknown type of polyps, now in need of repeat colonoscopy (See Attachment 1 for eligible interval).  Was screened with inadequate colonoscopy within the Program

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